Oral Microbiome is Associated With the Response to Chemoradiotherapy in Initial Inoperable Patients With Esophageal Squamous Cell Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-07-01

Brief Summary

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Esophageal cancer accounts for more than half of the world, seriously affecting people's health in China. 95% patients are squamous cell carcinoma. Surgery is the preferred treatment for early and middle stage esophageal cancer, but patients with clinical stage T4b or other surgical contraindications have no surgical opportunity. In recent years, radical chemoradiotherapy has played a key role in the treatment of local advanced esophageal cancer with some poor predicting biomarkers. Oral bacteria may play a pathogenic role in cancer and other chronic diseases by producing chemical carcinogens and inflammatory factors through direct metabolism. A large number of studies have also suggested that tooth loss and poor oral hygiene are closely related to upper digestive tract cancer, indicating the possible role of oral microorganisms in the occurrence and development of upper digestive tract cancer, and saliva is the main source of oral flora colonization. Therefore, it is worth further research to explore the interaction between microbial metabolism imbalance and radiotherapy in patients with esophageal cancer. In summary, we intend to conduct a prospective cohort study to explore the role of salivary microbes in radiotherapy in patients with initially inoperable patients with local advanced esophageal cancer.

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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma Chemoradiotherapy Initial Inoperable

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental

cancer

regular chemoradiotherapy

Intervention Type OTHER

regular chemoradiotherapy

Interventions

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regular chemoradiotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18-85 years old;

* Eastern Cooperative Oncology Group (ECOG) 0-2;
* Esophageal squamous cell carcinoma;
* cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;
* initial unresectable at initial diagnosis confirmed by thoracic surgeons;
* Treatment naive;
* No contraindications for adjuvant chemoradiotherapy;
* Signature of inform consent.

Exclusion Criteria

* • younger than 18 years old or older than 85 years old;

* ECOG\>2;
* Esophageal adenocarcinoma, small-cell cancer and other pathological types;
* cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination;
* Resectable at initial diagnosis confirmed by thoracic surgeons;
* Previous treatment of chemotherapy, radiotherapy, and other treatment;
* Contraindications for chemoradiotherapy;
* No signature of inform consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes